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| Name | Class |
|---|---|
| 1EQ, Inc. | INDUSTRY |
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Prenatal care is defined as preventive healthcare characterized by regular check-ups by doctors or midwives to treat and prevent potential health problems throughout the course of the pregnancy. The investigators propose that a mobile app for prenatal care has the potential to provide patient-tailored, risk-appropriate prenatal educational content and may facilitate vital sign and weight checks between visits. The investigators describe the methods used to develop and test the effectiveness of a mobile app for prenatal care to safely reduce the number of in-person visits to the obstetrician (OB) compared to standard of care.
This is a protocol for a multi-center quasi-randomized controlled trial to compare an intervention group receiving a prenatal care app, to a control group receiving usual care. The trial is being conducted at two diverse outpatient obstetric practices that are part of a single academic department of obstetrics in Washington, DC. Women who are between 18 and 40, who are visiting their OB for a first trimester routine visit, who have a confirmed desired pregnancy, who are not considered "high-risk," and who have an IOS, Android or Windows-based smart phone that they use regularly will be eligible for enrollment. The Investigators will measure the effect of a mobile app for prenatal care on:
To capture these outcomes, the investigators will administer patient surveys via telephone every 4 weeks during gestation and the immediate post-partum period, review the electronic medical record, and conduct in-depth interviews with a representative subset of patients after delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Babyscripts Prenatal App | Active Comparator | For patients allocated to the experimental group, they will be assisted in downloading the BRx app to their smartphone and set up the connected weight scale and blood pressure cuff. At time of enrollment, research assistant will also collect baseline demographic and clinical data. For patients allocated to this study arm, the clinician will be informed and therefore, will be receiving regular app-based education while the clinician will be receiving regular blood pressure and weight measurements. Following that communication, it will be the physicians' judgement to reduce in-person visits from usual care. |
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| Placebo | Placebo Comparator | For patients cared for by clinicians allocated to the control (usual care) arm, the clinician will discuss the management options and scheduling procedures with the patient in that clinician's usual fashion. The patient will not be given access to the BRx app but will consent to the study data collection and survey administration. All potential study subjects will receive standard medical care per DoD/VA Clinical Practice Guidelines for Management of the uncomplicated pregnancy (REF) and local preference by board-certified OB/GYN physicians. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Babyscripts Prenatal App | Device | The use of a mobile digital app to facilitate certain aspects of standard prenatal care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Visit Number | In discussions with OBs, it became clear that, patient safety notwithstanding, the advantages and disadvantages of a reduced visit schedule versus usual care were of greatest importance and so total visit number was selected as the primary outcome. We will measure total visit number by reviewing the EHR. All other outcomes will be secondary outcomes. | From first trimester up to postpartum, between 6 and 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational Weight Gain | We will assess gestational weight gain following enrollment until delivery. These measures will be obtained by health record review and review of data collected in the app. Data collection will be performed with a standardized data collection sheet and a 10% check for interrater reliability. | From first trimester up to postpartum, between 6 and 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew C Meltzer, MD, MS | The George Washington University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Washington University Hospital | Washington D.C. | District of Columbia | 20037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31042154 | Derived | Marko KI, Ganju N, Krapf JM, Gaba ND, Brown JA, Benham JJ, Oh J, Richards LM, Meltzer AC. A Mobile Prenatal Care App to Reduce In-Person Visits: Prospective Controlled Trial. JMIR Mhealth Uhealth. 2019 May 1;7(5):e10520. doi: 10.2196/10520. |
| Label | URL |
|---|---|
| site for mobile app | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| FWA00005945 | Informed Consent Form | View IPD |
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| ID | Title | Description |
|---|---|---|
| FG000 | Babyscripts Prenatal App | For patients allocated to the study group, they will be assisted in downloading the BRx app to their smartphone and set up the connected weight scale and blood pressure cuff. At time of enrollment, research assistant will also collect baseline demographic and clinical data. For patients who were allocated to the intervention arm, the clinician will told that they are in intervention group and therefore will be receiving regular app-based education and clinician will be receiving regular blood pressure and weight measurements. Following that communication, it will be the physicians' judgement to reduce in-person visits from usual care. Babyscripts Prenatal App: The use of a mobile digital app to facilitate certain aspects of standard prenatal care. |
| FG001 | Placebo | For patients cared for by clinicians allocated to the usual care arm, the clinician will discuss the management options and scheduling procedures with the parent in that clinician's usual fashion. The patient will not be given access to the BRx app but will consent to the study data collection and survey administration. All potential study subjects will receive standard medical care per DoD/VA Clinical Practice Guidelines for Management of the uncomplicated pregnancy (REF) and local preference by board-certified OB/GYN physicians. Placebo: No Mobile App, Usual care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Babyscripts Prenatal App | For patients allocated to the study group, they will be assisted in downloading the BRx app to their smartphone and set up the connected weight scale and blood pressure cuff. At time of enrollment, research assistant will also collect baseline demographic and clinical data. For patients who were allocated to the intervention arm, the clinician will told that they are in intervention group and therefore will be receiving regular app-based education and clinician will be receiving regular blood pressure and weight measurements. Following that communication, it will be the physicians' judgement to reduce in-person visits from usual care. Babyscripts Prenatal App: The use of a mobile digital app to facilitate certain aspects of standard prenatal care. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Visit Number | In discussions with OBs, it became clear that, patient safety notwithstanding, the advantages and disadvantages of a reduced visit schedule versus usual care were of greatest importance and so total visit number was selected as the primary outcome. We will measure total visit number by reviewing the EHR. All other outcomes will be secondary outcomes. | Posted | Mean | Standard Deviation | visits | From first trimester up to postpartum, between 6 and 9 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Babyscripts Prenatal App | For patients allocated to the study group, they will be assisted in downloading the BRx app to their smartphone and set up the connected weight scale and blood pressure cuff. At time of enrollment, research assistant will also collect baseline demographic and clinical data. For patients who were allocated to the intervention arm, the clinician will told that they are in intervention group and therefore will be receiving regular app-based education and clinician will be receiving regular blood pressure and weight measurements. Following that communication, it will be the physicians' judgement to reduce in-person visits from usual care. Babyscripts Prenatal App: The use of a mobile digital app to facilitate certain aspects of standard prenatal care. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew C. Meltzer | George Washington University School of Medicine & Health Sciences- Department of Emergency Medicine | 202-741-2952 | ameltzer@mfa.gwu.edu |
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| Placebo | Device | No Mobile App, Usual care |
|
| Post-Partum Survey | Individual Participant Data Set | View IPD |
| Prenatal Participant Data -22 | Individual Participant Data Set | View IPD |
| BG001 | Placebo | For patients cared for by clinicians allocated to the usual care arm, the clinician will discuss the management options and scheduling procedures with the parent in that clinician's usual fashion. The patient will not be given access to the BRx app but will consent to the study data collection and survey administration. All potential study subjects will receive standard medical care per DoD/VA Clinical Practice Guidelines for Management of the uncomplicated pregnancy (REF) and local preference by board-certified OB/GYN physicians. Placebo: No Mobile App, Usual care |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| College Graduate | Count of Participants | Participants |
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| Gravidity Per Patient | Count of Participants | Participants |
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| Parity Per Patient | Count of Participants | Participants |
|
| OG001 | Placebo | For patients cared for by clinicians allocated to the usual care arm, the clinician will discuss the management options and scheduling procedures with the parent in that clinician's usual fashion. The patient will not be given access to the BRx app but will consent to the study data collection and survey administration. All potential study subjects will receive standard medical care per DoD/VA Clinical Practice Guidelines for Management of the uncomplicated pregnancy (REF) and local preference by board-certified OB/GYN physicians. Placebo: No Mobile App, Usual care |
|
|
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| Secondary | Gestational Weight Gain | We will assess gestational weight gain following enrollment until delivery. These measures will be obtained by health record review and review of data collected in the app. Data collection will be performed with a standardized data collection sheet and a 10% check for interrater reliability. | Posted | Mean | Standard Deviation | pounds | From first trimester up to postpartum, between 6 and 9 months |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | Placebo | For patients cared for by clinicians allocated to the usual care arm, the clinician will discuss the management options and scheduling procedures with the parent in that clinician's usual fashion. The patient will not be given access to the BRx app but will consent to the study data collection and survey administration. All potential study subjects will receive standard medical care per DoD/VA Clinical Practice Guidelines for Management of the uncomplicated pregnancy (REF) and local preference by board-certified OB/GYN physicians. Placebo: No Mobile App, Usual care | 0 | 51 | 0 | 51 | 0 | 51 |
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| Overweight (25<BMI<30) |
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| Obese (BMI>30) |
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